FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1873889
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17927
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 1, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD HAD (B)(6). IT WAS NOTED THAT THERE WAS APPROPRIATE FUNCTION OF THE SYSTEM PRIOR TO THE EXPLANT PROCEDURE. THE RA LEAD WAS SENT FOR A CULTURE BY THE PHYSICIAN AND MAY BE RETURNED AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | 0137| 4517| 4086| H219 |